Connector device for the sterile connection of tubes

ABSTRACT

A connector for forming a sterile connection between two tubes, comprising first and second parts which comprise connectable conduits and which can mate, first and second covers which can be removed from the so-mated parts to expose connectable ends of the first and second conduits, so that the conduits can then be connected.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a national stage application under 35 U.S.C. Section 371 of PCTapplication PCT/PCT/EP02/12657, filed on 22 Sep. 2004, which claims thebenefit of GB0127224.4, filed on 13 Nov. 2001.

FIELD OF THE INVENTION

This invention relates generally to a connector device suitable forconnecting two conduits.

BACKGROUND

A connection device for sterile connection of tubes is often required insituations where, for example, pharmaceutical substances such asvaccines etc. are manipulated and transferred via such conduits from onecontainer or another type of enclosure to another. Such a connector isdisclosed in U.S. Pat. No. 6,341,902 but in practice the connectordisclosed therein can only connect small diameter tubing.

SUMMARY OF THE INVENTION

In one aspect is provided a means by which two such conduits may beconnected whilst maintaining sterility. Other aspects will be apparentfrom the following description.

In one aspect is provided a connector for connecting two conduits thatcomprises,

a first connector part and a second connector part which can matetogether to form an enclosure between them bounded by a sterile seal,

the first connector part and second connector part having respectivefirst and second conduits passing through them, the conduits beingrelatively moveable within the enclosure formed on mating of the firstand second connector parts to form a mating connection between the firstand second conduits,

in the unmated state of the first and second connector parts the firstand second conduits being covered by respective first and secondremovable covers which can mate with each other and which formrespective seals with the respective first and second connector parts toisolate the ends of the conduits from the ambient environment,

configured such that on mating of the first and second connector partsthe first and second removable covers also mate and form a sterile sealbetween them, and the mated covers may be separated from the respectivefirst and second parts and received within the enclosure, to allow theconduits to relatively move and come into mating connection within theenclosure.

In one aspect there is a sterile seal between the first connector partand first removable cover; a sterile seal between the second connectorpart and second removable cover; a sterile seal between the firstconnector part and second connector part when mated; and a sterile sealbetween the first removable cover and the second removable cover whenmated, and all of these seals meet at a common seal line. In oneembodiment, this common seal line is the line at which the mated firstand second removable covers are separated from the respective first andsecond parts.

An embodiment of the connector comprises;

a first connector part having a first sealing surface through whichpasses a first conduit having a first open end on one side of thesealing surface,

a first removable cover engageable with the first connector part andwhich when so engaged forms a first seal between the first cover and thefirst part, and together with the first connector part forms a firstenclosure enclosing the first open end,

a second connector part defining at least part of a second enclosure,and having a second sealing surface which can be sealingly mated withthe first sealing surface to form a second seal between these surfaces,an opening through the second sealing surface,

a second removable cover engageable with the second connector part whichwhen in place closes the opening at a third seal, and which togetherwith the second connector part forms a second enclosure within thesecond connector part, and the second removable cover can mate with thefirst removable cover,

a second conduit terminating in a second open end within the secondenclosure and having an open end outside the second enclosure,

wherein in operation

the first and second parts mate to form the second seal between thefirst and second sealing surfaces,

when so mated the first and second covers mate to form a fourth sealbetween the first and second covers, and the mated first and secondcovers enclosing between them parts of the first and second covers thatbefore mating were exposed to the ambient environment,

the mated first and second covers are detached from the mated first andsecond parts to expose the first and second ends respectively of thefirst and second conduits to each other,

the first and second ends respectively of the first and second conduitsare moveable relatively toward each other, and are moved relative toeach other into communication, and wherein,

the first, second, third and fourth seals meet along a common seal line,and the mated first and second covers detach from the mated first andsecond parts at this seal line.

In one aspect the first and second sealing surfaces comprisecorrespondingly shaped flange surfaces which meet in operation to form asterile first seal between the first and second parts. The first and/orsecond sealing surfaces may comprise a compression seal, e.g. comprisinga compressible elastomeric seal e.g. a washer, which compresses againsta mating part of the second or first sealing surface. In one aspect thefirst and second parts have mating parts such as co-operating screwthreads to facilitate their mating together.

In one aspect the first and second conduits are tubes, and therespective first and second ends are mating ends which can mate to forma fluid-tight communication, for example they may be male and femalemating ends.

In one aspect the first removable cover can fit over the first open endof the first conduit, and the first part and first cover can have matingparts such as co-operating screw threads to facilitate the sealing ofthe cover against the first part. In one aspect a compression seal, e.g.a compressible elastomeric washer, is provided between the first coverand the first part when the cover is in place to facilitate a sterileseal. For example a part of the first connector part adjacent to thefirst open end of the conduit may be a concave surface defining at leastpart of the first enclosure, and the first removable cover may comprisea convex facing surface defining another part of the first enclosure.

In one aspect the second removable cover and the opening through thesecond connector part are provided with mating parts such as screwthreads to facilitate the sealing of the cover against the second partto seal the opening.

In one aspect a compression seal, e.g. a compressible elastomericwasher, is provided between the second cover and the second part whenthe cover is in place to facilitate a sterile seal.

In one aspect the second removable cover may be detached from the secondconnector part by a movement inwardly into the second enclosure. In oneembodiment, the second removable cover is completely detachable from thepart of the second connector part that comprises the perimeter of theopening.

In one aspect the first and second covers are provided with mating partssuch as respective co-operating screw threads to facilitate their matingtogether.

In one aspect the fourth seal between the first and second removablecovers is facilitated by a compression seal between them, for example acompressible elastomeric washer.

In one aspect the mated first and second covers are detachable from themated first and second parts by unscrewing of the second cover from thesecond part.

In one aspect the so-detached mated covers are received within thesecond enclosure, i.e. within the second connector part.

In one aspect the so-mated covers are unscrewed from the second part byengagement of the second conduit, e.g. the second end of the secondconduit, with the mated covers, and rotational movement of the secondconduit communicated to the mated covers.

In one aspect the first and second conduits are made moveable relativeto each other by means of a construction of the second part and thesecond conduit by which the second conduit can move relative to thesecond part. For example the second part and the second conduit maycomprise relatively moveable telescoping sleeves, the second conduitbeing the inner sleeve. In one embodiment, between such sleeves there isa seal e.g. an elastomeric washer, relative to which the sleeves mayslide relative to each other, to isolate the interior of the enclosurewithin the second part from the outside environment. A construction ofthe second conduit and second part in the firm of two such sleeves canalso facilitate the above-mentioned rotational movement of the conduitto unscrew the mated covers, in that the sleeves may be rotatablerelative to each other, and the second conduit may be rotatable withinthe sleeve of the second part. Furthermore the above-mentionedtelescoping movement of such sleeves facilitates the engagement of thesecond conduit with the mated covers by means of the second conduitbeing moveable by the telescoping movement into a position in which thesecond end of the second conduit engages with the mated covers, e.g. bymeans of a male-female engagement of the second end with a female socketon the part of the second cover which faces the interior of the secondenclosure.

The second part may be provided with means to assist the detachment ofthe mated first and second covers from the second part. For example if,as in the above-described construction, the so-mated covers areunscrewed from the second part by engagement of the second conduit withthe mated covers, and the second conduit is moveable relative to thesecond connector part, the second connector part may include one or moreabutment part(s) against which the mated covers may abut, for example todisplace them from the second conduit. If the second connector partcomprises sleeves as described above, then an abutment part may bepositioned such that relative longitudinal and/or rotational movement ofthe sleeves, e.g. of the second conduit within the outer sleeve of thesecond part, may cause the abutment part(s) to abut against the matedcovers and the mated covers to fall off the second conduit into theenclosure within the second part.

When the second conduit and connector part comprise the sleevesdescribed above and are capable of relative rotational and longitudinalmotion, then the sleeves may have guide means to guide the sleeves indefined rotational and/or longitudinal motion., i.e. in defineddirections and to defined distances. Such guide means may for examplecomprise one or more sets(s) of engaging finger(s) and guide track(s)e.g. a guide groove, which the guide finger follows. Such guide meanscan for example ensure that the sleeves can only rotate relative to eachother to the extent necessary to unscrew the mated first and secondcovers from the second part.

The connector device of the invention may be provided with non-re-useconnection means, e.g. snap fit connections to prevent the device frombeing disconnected and re-used. This can prevent re-use of the deviceand consequent contamination. For example such connections can beprovided between the first and second parts to lock them together onceengaged.

As a further safety feature the connector device of the invention may beprovided with means to prevent the first and/or second covers from beingseparated from the respective first and second parts until the first andsecond parts have mated and established the second seal between them.For example if the connector device is constructed so that the secondseal can be separated from the second part by a movement of the secondconduit relative to the second connector part, the second conduit andthe second connector part may have respective cooperating means torestrain the second conduit from moving relative to the second part, andthese co-operating means may be disengaged upon mating of the first andsecond connector parts.

If the above-mentioned first and second connector parts, and/or firstand second removable covers which mate together do so by means ofco-operating screw threads then preferably non-return ratchet means areprovided between these mating parts to prevent them from becomingunscrewed again. Such ratchet means are also advantageous when the abovementioned first removable cover mates with the first connector part bymeans of cooperating screw threads, and/or the second removable covermates with the second connector part by means of co-operating screwthreads, by preventing the mated first and second connector parts, andthe mated first and second covers, from becoming un-mated when the matedfirst and second removable covers are detached from the mated first andsecond connector parts. Such unwanted un-matings could breach sterileseals between them and allow contamination.

The parts of the connector, e.g. the above mentioned first and secondparts, covers etc., other than specifically elastomeric parts, may bemade of robust plastics or metals, preferably of materials which caneasily be sterilised, e.g. by heat, radiation etc. without sufferingdamage. Compression seals are suitably made of compressible elastomericmaterial such as synthetic or natural rubber.

It is an important feature of this invention that the first, second,third and fourth seals meet along a common seal line, and the matedfirst and second covers detach from the mated first and second parts atthis common seal line. This seal line can define a single line ofnon-confidence between all the above mentioned parts of the connectorwhich mate and separate, enabling a construction in which the interiorof the connector can be maintained sterile without opportunity formicro-organisms to infiltrate into the region where the ends of the twoconduits meet.

In one embodiment, this feature is achieved by the first seal betweenthe first cover and the first part being provided by a first compressionseal in the form of a ring shaped elastomeric washer having an outer rimin the shape of a ring shaped edge, e.g. of a bi-conical shape with bothconical surfaces meeting at their base, and the third seal between thesecond removable cover and the opening also being provided by a secondcompression seal in the form of a ring shaped washer having an inwardfacing rim in the shape of an inward facing edge. In this constructionthe second seal between the first and second sealing surfaces is formedbetween the first seating surface and the second compression seal, andthe fourth seal between the first and second covers is formed betweenthe second cover and the first compression seal. In this embodiment,when the first and second parts are mated and the first and secondcovers are engaged the respective outward facing edge of the firstcompression seal and the inward facing edge of the second compressionseal meet to define the common seal line. In this embodiment as themated first and second covers detach from the mated first and secondparts the outward facing edge of the first compression seal becomesseparated from the inward facing edge of the second compression sealalong this common seal line.

The invention will now be described by way of example only withreference to the accompanying Figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows one embodiment of the presently disclosed device inlongitudinal view, and, as discussed in the description below, shows thedevice before the two parts are mated.

FIG. 2 shows one embodiment of the presently disclosed device inlongitudinal view and, as discussed in the description below, shows thedevice before the two parts are mated. Immediately to the right of thelongitudinal view is a surface schematic view of the guide groove 220and guide finger 219.

FIG. 3 shows one embodiment of the presently disclosed device inlongitudinal view and, as discussed in the description below, shows onephase of its operation in which the two parts are mated. Immediately tothe right of the longitudinal view is a surface schematic view of theguide groove 220 and guide finger 219.

FIG. 4 shows one embodiment of the presently disclosed device inlongitudinal view and, as discussed in the description below, shows onephase of its operation in which the two parts are mated. Immediately tothe right of the longitudinal view is a surface schematic view of theguide groove 220 and guide finger 219.

FIG. 5 shows one embodiment of the presently disclosed device inlongitudinal view and, as discussed in the description below, shows onephase of its operation in which the two parts are mated. Immediately tothe right of the longitudinal view is a surface schematic view of theguide groove 220 and guide finger 219.

FIG. 6 shows one embodiment of the presently disclosed device inlongitudinal view and, as discussed in the description below, shows onephase of its operation in which the two parts are mated. Immediately tothe right of the longitudinal view is a surface schematic view of theguide groove 220 and guide finger 219.

FIG. 7 shows one embodiment of the presently disclosed device inlongitudinal view and, as discussed in the description below, shows onephase of its operation in which the two parts are mated. Immediately tothe right of the longitudinal view is a surface schematic view of theguide groove 220 and guide finger 219.

FIG. 8 shows one embodiment of the presently disclosed device inlongitudinal view and, as discussed in the description below, shows onephase of its operation in which the two parts are mated. Immediately tothe right of the longitudinal view is a surface schematic view of theguide groove 220 and guide finger 219.

FIG. 9 shows a cross section of one embodiment of the presentlydisclosed device, as discussed in the description below. Immediately tothe right of the longitudinal view is a surface schematic view of theguide groove 220 and guide finger 219.

FIG. 10A shows one embodiment of the presently disclosed device in crosssection, as discussed in the description below.

FIG. 10B shows one embodiment of the presently disclosed device in crosssection, as discussed in the description below.

FIG. 10C shows one embodiment of the presently disclosed device in crosssection, as discussed in the description below.

FIG. 11 shows another embodiment of the presently disclosed connectordevice.

FIG. 12A-12D show an embodiment of the presently connector device moresimply and schematically.

DETAILED DESCRIPTION

A seal which maintains the sterility of the interior of an enclosurebounded by the seal from entry of micro-orgianisms from the exterior ofthe seal is called herein a “sterile seal”.

Parts referred to in FIGS. 1–12:

10 first connector part

11 screw thread

12 first sealing surface

13 first conduit

13A first open end of first conduit

13B second open end of first conduit

14 flexible plastics material tube

15 cylindrical body

16 first removable cover

17 screw thread connection

18 first seal, between the first cover 16 and the first part 10

19 compressible elastomeric washer

19A outer rim of washer 19

110 first enclosure

111 protective cap

112 screw thread

20 second connector part

21 screw thread

22 second sealing surface

23, 24 sub assemblies of second part 20

25 second enclosure

26 second compression seal

26A inward facing rim of seal 26

27 opening through second sealing surface 22

28 second removable cover

29 screw thread connection

210 third seal between cover 28 and compression seal 26

211 part of the second connector part 20 in the form of a cylindricalsleeve

212 second conduit

212A second open end of second conduit 212

212B opposite open end of second conduit 212

213 polygonal socket in cover 28

214 flexible plastics material tube

215 part of conduit 212 made into a cylindrical outer sleeve

215A part of sleeve 215 of larger diameter

216, 217 elastomeric seals

218 integral flange

219 guide finger

220 guide groove

221 protective cap

222 second seal between first and second sealing surfaces

223 screw thread

224 fourth seal between first and second covers

225 abutment surface of enclosure 25

226 arm

227 guide pin

228 guide groove

1234 common seal line

2201, 2202, 2203, 2204, 2205 five lengths of groove 220

30,31 non return ratchets and co-operating teeth

32 outer collar

33 ratchet springs

34 teeth

35 small sleeve

36 small sleeve

NB: for clarity each feature is not numbered in every figure.

Referring to FIG. 1, a connector for connecting two conduits is shown.This comprises a first connector part 10 overall and a second connectorpart 20 overall. The first part 10 and second part 20 can be matedtogether by means of respective screw threads 11 and 21. The first part10 and second part 20 have a respective first sealing surface 12 and asecond sealing surface 22, which are respective flange surfaces. Parts10 and 20 are made of robust plastics material.

Through the first part 10 passes a first conduit 13 having a first openend 13A on one side of the sealing surface 12, viz., the side that facespart 20 during assembly as described below. The first conduit 13 is atubular conduit and has a second open end 13B on the other side of thesealing surface 12, which can be connected to another tube, e.g. aflexible plastics material tube 14. The first part 10 is overall in theform of a cylindrical body 15, with the first sealing surface 12 forminga closed end wall of the body 15.

Covering the open end 13A of the conduit 13 is a first removable cover16. This is engageable with the first connector part 10 by means of ascrew thread connection 17. When engaged with first part 10 the cover 16forms a first seal 18 between the first cover 16 and the first part 10,provided by a compression seal being a compressible elastomeric washer19 between the first cover 16 and the first part 10, and this is asterile seal. Washer 19 is in the shape of a ring shaped washer havingan outer rim 19A in the shape of a ring shaped edge, and is generally ofa bi-truncated conical shape with both conical surfaces meeting at theirbase, i.e. edge 19A. The first connector part 10 and the cover 16 form afirst enclosure 110 enclosing the first open end. The seal 18 is asterile seal isolating this enclosure 110 from the outside environment.Prior to use the cover 16 and surface 12 of the first part 10 may beprotected by cap 111. The part of the first connector part 10 adjacentto the open end 13A of the first conduit is formed into a concavity, andthe facing surface of first cover 16 is also concave to define betweenthem the first enclosure 110.

Second connector part 20 is in the form of sub-assemblies 23 and 24 forease of manufacturing and which fit sealingly together. Part 20 definesa second enclosure 25, and the sub-assemblies 23, 24 comprise body partsof the second part 20 forming surrounding walls of the second enclosure25.

Second sealing surface 22 partly comprises a second compression seal 26in the form of a ring shaped washer having an inward facing rim 26A inthe form of an inward facing edge. When the first part and second part20 are mated, as will be seen below, this second compression seal 26forms a second seal between the first sealing surface 12 and the secondsealing surface 22.

There is an opening 27 into second enclosure 25 through the secondsealing surface 22, and there is a second removable cover 28, which isengageable with the second connector part 20 by means of screw threadconnection 29 to thereby close the opening 27. The second enclosure 25is thereby formed in part by the body parts 23,24 and the secondremovable cover 28. The second removable cover 28 is configured toconnect with part 23 from the direction of the interior of enclosure 25.When in place as shown in FIG. 1 cover 28 closes opening 27 and a thirdseal 210 is formed between the cover 28 and the compression seal 26. Apart 211 of the second connector part 20 is integrally in the form of acylindrical sleeve extending longitudinally away from the opening 27,and open into the enclosure 25.

A second conduit 212 passes internally along sleeve 211 into enclosure25, and terminates in a second open end 212A within the secondenclosure. Conduit 212 is a cylindrical rigid tube which can rotatewithin sleeve 211, and end 212A of conduit 212 is engageable with cover28, e.g. by means of the end 212A being polygonal and fitting in amale-female manner into a matching polygonal socket 213 in cover 28, orby means of mating splines on the cover 28 and end 212, so that rotationof conduit 212 when engaged with cover 28 may be communicated to cover28, but the end 212A may be freely longitudinally inserted into andwithdrawn from the socket 213 in cover 28. The socket 213 has a closedend facing the first part 10, and covers the end 212A of conduit 212.Conduit 12 has an opposite open 212B which can be connected to anotherflexible tube 214.

Part 215 of conduit 212 is integrally made into a cylindrical outersleeve within which sleeve 211 closely fits and can freely rotate.Elastomeric seals 216 and 217 between respectively sleeve 211 and 212,and between sleeve 211 and 215 are sterile seals which isolate enclosure25 from the environment.

Sleeve 211 is provided with an internal flange 218 in which part of theouter edge of which is a guide finger 219. Part 215A of outer sleeve 215is made of increased diameter and there is a co-operating guide groove220 in sleeve 215, to guide the parts of the connector along definedpaths, as will be explained below with reference to FIG. 9. The opening27 may be covered prior to use by protective cap 221.

The operation of the device of FIG. 1 will now be described withreference to FIGS. 2–10.

As seen in FIG. 2 the caps 111 and 221 have been removed and parts 10and 20 are brought toward each other so that screw threads 11, 21 onrespectively first part 10 and second part 20 can engage by means of therotation of part 10 relative to part 20 indicated by the arrow in FIG.2. As will be explained later by reference to FIG. 10 a ratchetmechanism 30 31 co-operating between parts 10 and 20 permits relativerotation in the direction necessary to mate the screw threads 11, 21,but does not allow relative rotation in the opposite direction tounscrew them, and similarly a ratchet spring and teeth mechanism 33, 34between the covers 16, 28 permits relative rotation in the directionnecessary to mate the screw threads 112, 223 but does not allow relativerotation in the opposite direction to unscrew them.

As seen in FIG. 3 first part 10 and second part 20 have mated viarespective screw threads 11, 21. A second seal 222 has been formedbetween the sealing surface 12 of the first part 10, and the sealingsurface 22 of the second part 20, in which the compression seal 26 iscompressed between these surfaces 12,22. This seal 222 is a sterileseal, preventing passage of micro-organisms from the outsideenvironment. The mating of the first 10 and second 20 parts byengagement of screw threads 11, 21 also causes the first 16 and second28 covers to mate, by means of respective screw threads 112, 223 to forma fourth seal 224 between the first 16 and second cover 28, that is,between cover 28 and first compression seal 19. The pitch of the screwthreads 11, 21 and 112, 223 is such that when parts 10 and 20 arescrewed tight, i.e. to their fullest extent, covers 16 and 28 are alsoscrewed tight, i.e. to their fullest extent. When mated in this way, themated first 16 and second 28 covers between them enclose all those partsof the first 16 and second 28 covers that before mating were exposed tothe ambient environment. Therefore any micro-organisms etc. that mayhave contaminated the outer surface of covers 16, 28 are now sealedbetween covers 16 and 28. As seen in FIG. 3 the first 18, second 222,third 210 and fourth 224 seals all meet along a common seal line 1234,being the line along which the edges of the respectively inwardly andoutwardly facing bi-conical surfaces of the rims 19A and 26A meet.

As seen in FIG. 4, mated parts 10, 20 are now rotated relative to eachother, in the direction indicated by the arrow, relative to conduit 212,which can freely rotate within sleeve part 211 of part 20. Ratchet parts30, 31 and 33, 34 prevent the mated parts 10, 20 and 16,28 from becomingunscrewed as described above. This relative rotation is alsocommunicated to second cover 28, which causes the mated covers 16, 28 torotate relative to parts 10,20 and causes the mated covers 16,28 tobecome unscrewed at screw thread connection 17, 29 from parts 10,20.

As seen in FIGS. 5 and 6, the unscrewing of the mated first 16 andsecond 28 covers results in these mated covers 16,28 becoming detachedfrom the mated first 10 and second 20 parts. The conduit 212 can movelongitudinally within sleeve 211 away from opening 27, and thislongitudinal movement of the conduit 212 relative to sleeve 211 causesthe mated covers 16,28 to first become distanced from the end 13A ofconduit 13, then to abut against abutment surface 225 of enclosure 25i.e. the wall of the enclosure 25 opposite to opening 27.

As seen in FIG. 6 this causes the mated covers 16,28 to fall clear ofend 212A of conduit 212, consequently exposing the first 13A and second212A ends respectively of the first 13 and second 212 conduits to eachother within enclosure 25. The mated covers 16,28 are received withinenclosure 25 which is of such shape and dimensions that the receivedmated covers 16,28 do not interfere with further operation of thedevice.

As seen in FIGS. 7 and 8 the conduit 212 has been slid within outersleeve 211 toward end 13A of conduit 13, and the first 13A and second212A ends of the first 13 and second 212 conduits have come intocommunication. The ends 13A and 212A are mating male-female connectionsand further relative rotation as shown in FIG. 8 caused them to form afluid tight fit, and furthermore the finger 219 moves into its finallocking position in groove 220. Fluid can then flow from tube 14 throughthe mated connector 10, 20 to tube 214 and vice versa. The ends 13A and212A may co-operate as shown by means of a frictional engagement, orthey may have connection means (not shown), e.g. engaging screw threadsor bayonet connections etc., and they may be provided with further seals(not shown) to facilitate their fluid tight connection.

As seen in FIG. 3, when the first 10 and second 20 parts are mated asdescribed above, the first 18, second 222, third 210 and fourth 224seals all meet along a common seal line 1234, being the line along whichthe rims 19A and 26A meet. The mated first 16 and second 28 coversdetach from the mated first 10 and second 20 parts at this common sealline 1234. This means that all those parts of the connector which priorto mating of the first 10 and second 20 parts were exposed to theambient environment can be separated from all the sterile parts of theconnector across this line 1234, which establishes a line ofnon-confidence.

In use, the parts 10 and 20 may be provided in a sterile pack (notshown) e.g. a sealed plastic bag. The conduits 13 and 212 may beconnected to respective tubes 14 and 214 in separate sterileenvironments, and tubes 14 and 214 may themselves be connected torespective sterile containers containing respective sterile fluids (notshown). The containers with connected tubes 14, 214 and connected parts10,20 may then be transported through a non-sterile environment andconnected as described above so that sterile fluid may flow between themwithout contamination of the fluid by micro-organisms in the ambientenvironment.

FIG. 10 shows cross sections through the mated parts 10, 20 as shown inFIG. 3 at lines B—B and also through the mated first and second covers16, at lines C—C in FIG. 4, looking in the direction indicated by thearrows, and shows non-return ratchet springs 30 and co-operating teeth31 integrally respectively on part 15 and an outer collar 32 of part 20to prevent the parts 10, 20 from becoming disconnected during use. FIG.10 also shows co-operating non-return ratchet springs 33 and teeth 34 onrespectively the first removable cover 16 and second removable cover 28,to prevent disconnection of the covers 16,28 accidentally. The ratchetsprings 33 are integrally formed on the outer surface of a small sleeve35 which surrounds the polygonal socket 213 in cover 28, and the teeth34 are integrally formed on the inner surface of the small sleeve 36, onthe outer surface of which is the screw thread 112.

FIG. 10 also shows the polygonal shape of the end 212A of conduit 212and the socket 213 in second cover 28.

Referring to FIG. 11 another embodiment of the connector device isshown. It will be apparent that the overall construction and operationof the device shown in FIG. 11 is analogous to that of FIGS. 1–10, i.e.comprising the two parts 1110 and 1120. The device of FIG. 11 differsfrom FIGS. 1–10 in that the second conduit 11212 has been madeergonomically shorter than the conduit 212 of FIGS. 1–10, and a singleseal 11216 is used. Also the enclosure 1125 has been made oval insection as cut across the length direction of the conduit 11212 with theconduit in the upper half of the oval to provide more space to receivethe mated first and second covers 1116, 1128. Also the guide finger 219and guide groove 220 are replaced by an arm 226 extending from sleeve215 and terminating in a guide pin 227 which can follow a guide groove228 in the outer surface of the part 1123 in a manner analogous to thepin 219 and groove 220 of FIGS. 1–10. Also as a safety feature toprevent premature operation of the part 1120 i.e. separation of thecover 1128 from part 1123, the pin 227 may be initially locked immovablyin place in groove 228 and unable to move therein, and the pin 227 maybe released from this locked position only when parts 1110 and 1120mate. This may be achieved by a resilient biasing of the pin into alocked position e.g. by the arm 226 being resilient, and by for examplea cam surface (not shown) on part 1120 which engages a cam surface (notshown) acting on the pin 227 when parts 1110 and 1120 mate to therebyurge the pin 227 out of this locked position into an unlocked positionin which it can move in groove 228 and allow operation of the connectordevice as described above.

FIG. 12 shows the construction and operation of an embodiment of thepresently disclosed connector more schematically, clarifying theprinciple of the embodiments of FIGS. 1 to 11.

The connector comprises a first connector part 10 and a second connectorpart 20, which can mate together to form an enclosure 25 between thembounded by a sterile seal but which in FIG. 12A are shown un-mated butadjacent. The first connector part 10 and second connector part 20 haverespective first and second conduits 13,212 passing through them. Thesecond conduit 212 is slideably relative to second connector part 20within the sleeve 211, sterile sliding seals 216,217 being provided tomaintain sterility. In this unmated state of the first and secondconnector parts 10,20 the ends 13A, 212A of the first and secondconduits 13,212 are covered by respective first and second removablecovers 16,28 which can mate with each other and which form respectiveseals 18,210 with the respective first and second connector parts 10,20to isolate the ends 13A,212A of the conduits 13,212 from the ambientenvironment.

In FIG. 12B the parts 10,20 are shown mated by a relative translationmovement as shown by the arrows. A sterile seal 222 has formed betweenthe first and second parts, and the first and second removable covers16,28 have also mated with each other and formed a sterile seal 224 witheach other. In this configuration the seals between the first and secondparts 10,20, between the respective first and second movable covers16,28 and the parts 10,20 all meet at a common seal line 1234.

In the mated configuration shown in FIG. 12C, the mated first and secondcovers 16,28 have become separated from the respective first and secondparts 10,20 and received within the enclosure 25. The common seal line1234 is the line at which the mated first and second removable covers16,28 are separated from the respective first and second parts 10,20.

As shown in FIG. 12D the second conduit 212 is moved relative to thefirst conduit 13 and comes into mating connection with the first conduit13 within the enclosure 25, the seals 216,217 maintaining the enclosure25 sterile.

1. A connector for connecting two conduits which comprises, a firstconnector part and a second connector part which mate together to forman enclosure between them bounded by a sterile seal, the first connectorpart and second connector part having respective first and secondconduits passing through them, the conduits being relatively moveablewithin the enclosure formed on mating of the first and second connectorparts to form a mating connection between the first and second conduits,in the unmated state of the first and second connector parts the firstand second conduits being covered by respective first and secondremovable covers which can mate with each other and form a sterile sealbetween them, and which form respective seals with the respective firstand second connector parts to isolate the ends of the conduits from theambient environment, wherein in operation, on mating of the first andsecond connector parts the first and second removable covers also mate,then the mated covers are detached from the mated respective first andsecond parts and are received within the enclosure, to thereby exposethe respective first and second ends of the first and second conduits toeach other within the enclosure, and to allow the conduits to relativelymove and come into mating connection within the enclosure.
 2. Aconnector according to claim 1 wherein there is a sterile seal betweenthe first connector part and first removable cover; a sterile sealbetween the second connector part and second removable cover; a sterileseal between the first connector part and second connector part whenmated; and a sterile seal between the first removable cover and thesecond removable cover when mated, and all of these seals meet at acommon seal line.
 3. A connector according to claim 1 wherein, a firstconnector part having a first sealing surface through which passes afirst conduit having a first open end on one side of the sealingsurface, a first removable cover engageable with the first connectorpart and which when so engaged forms a first seal between the firstcover and the first part, and together with the first connector partforms a first enclosure enclosing the first open end, a second connectorpart defining at least part of a second enclosure, and having a secondsealing surface which can be sealingly mated with the first sealingsurface to form a second seal between these surfaces, an opening throughthe second sealing surface, a second removable cover engageable with thesecond connector part which when in place closes the opening at a thirdseal, and which together with the second connector part forms a secondenclosure within the second connector part, and the second removablecover can mate with the first removable cover, a second conduitterminating in a second open end within the second enclosure and havingan open end outside the second enclosure, wherein in operation the firstand second parts mate to form the second seal between the first andsecond sealing surfaces, when so mated the first and second covers mateto form a fourth seal between the first and second covers, and the matedfirst and second covers enclose between them parts of the first andsecond covers that before mating were exposed to the ambientenvironment, the mated first and second covers are detached from themated first and second parts to expose the first and second endsrespectively of the first and second conduits to each other, the firstand second ends respectively of the first and second conduits aremoveable relatively toward each other, and are moved relative to eachother into communication, and wherein, the first, second, third andfourth seals meet along a common seal line, and the mated first andsecond covers detach from the mated first and second parts at this sealline.
 4. A connector according to claim 3 wherein the first and secondconduits are tubes, and the respective first and second ends are matingends which can mate to form a fluid-tight communication.
 5. A connectoraccording to claim 3 wherein the first part and first cover haveco-operating screw threads to facilitate the sealing of the coveragainst the first part, the second removable cover and the openingthrough the second connector part have screw threads to facilitate thesealing of the cover against the second part to seal the opening, andthe first and second covers have co-operating screw threads tofacilitate their mating together.
 6. A connector according to claim 3,wherein the second removable cover is detachable from the secondconnector part by a movement inwardly into the second enclosure.
 7. Aconnector according to claim 1 wherein the mated first and second coversare detachable from the mated first and second parts by unscrewing ofthe second cover from the second part, and the so-mated covers can beunscrewed from the second part by engagement of the second conduit withthe mated covers and rotational movement of the second conduit iscommunicated to the mated covers.
 8. A connector according to claim 7wherein when engaged with the second conduit the mated first and secondcovers may be carried by the second conduit away from the opening.
 9. Aconnector according to claim 1 wherein the second connector part and thesecond conduit comprise relatively moveable telescoping sleeves wherebythe second conduit may be moved relative to the second part away fromthe opening.
 10. A connector according to claim 7, wherein the secondconnector part includes one or more abutment part(s) against which themated first and second covers may abut to displace them from the secondconduit.
 11. A connector according to claim 1 wherein the detached matedcovers are received within the second connector part.
 12. A connectoraccording to claim 9 wherein the sleeves have guide means to guide thesleeves in defined rotational and/or longitudinal motion.
 13. Aconnector according to claim 1 wherein non-re-use connection meansprevent the first and second connector parts from being disconnected andre-used.
 14. A connector according to claim 13 wherein the first andsecond connector parts, and/or first and second removable covers whichmate together do so by means of co-operating screw threads and saidnon-re-use connection means comprise non-return ratchet means.
 15. Aconnector according to claim 2 wherein the common seal line defines asingle line of non-confidence between all the parts of the connectorwhich mate and separate.
 16. A connector according to claim 15 whereinthe first seal between the first cover and the first part is provided bya first compression seal in the form of a ring shaped elastomeric washerhaving an outer rim in the shape of a ring shaped edge, the third sealbetween the second removable cover and the opening also being providedby a second compression seal in the form of a ring shaped washer havingan inward facing rim in the shape of an inward facing edge, the secondseal between the first and second sealing surfaces is formed between thefirst sealing surface and the second compression seal, and the fourthseal between the first and second covers is formed between the secondcover and the first compression seal.
 17. A connector according to claim16 wherein when the first and second parts are mated and the first andsecond covers are mated the respective outward facing edge of the firstcompression seal and the inward facing edge of the second compressionseal meet to define the common seal line, and as the mated first andsecond covers detach from the mated first and second parts the outwardfacing edge of the first compression seal becomes separated from theinward facing edge of the second compression seal along this common sealline.
 18. A connector according to claim 1, with means to prevent thefirst and/or second covers from being separated from the respectivefirst and second parts until the first and second parts have mated andthe second seal is established between them.